mp-092 - mp-092 - Medical Policies
Transtympanic Micropressure Applications as a Treatment of Ménière’s Disease
Policy Number: MP-092
Latest Review Date: August 2022
Transtympanic micropressure applications as a treatment of Meniere’s disease is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Meniere's disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Transtympanic pressure treatment has been proposed as an alternative treatment for Meniere disease. This treatment involves use of a handheld device (e.g., Meniett) that delivers air pressure pulses to the ear.
Meniere disease is an idiopathic disorder of the inner ear characterized by episodes of vertigo, fluctuating hearing loss, tinnitus, and ear pressure. The vertigo attacks are often unpredictable, incapacitating, and may impede activities of daily living. Therapy addresses symptoms, not the underlying pathophysiology. Although the pathophysiology of Meniere disease is not precisely known, it is thought to be related to a disturbance in the pressure-volume relationship of the endolymph within the inner ear.
Conservative therapy includes a low sodium diet and diuretics to reduce fluid accumulation (i.e., hydrops) and pharmacologic therapy to reduce vestibular symptoms. Persons who do not respond to these conservative measures may receive gentamicin drops in the ear, as a technique of chemical labyrinthectomy to ablate vestibular function on the affected side. No therapy is available to restore hearing loss.
There has been interest in developing a more physiologic approach to treatment by applying local pressure treatment to restore the underlying fluid homeostasis. Researchers have noted that symptoms of Meniere's disease improve with fluctuations in ambient pressure, and patients with acute vertigo have been successfully treated in hypobaric chambers. It is hypothesized that the application of low-frequency, low-amplitude pressure pulse to the middle ear functions to evacuate endolymphatic fluids from the inner ear, thus relieving vertigo.
Transtympanic micropressure treatment for Meniere’s disease involves use of a handheld air pressure generator (Meniett) that delivers intermittent complex pressure pulses. For this device to be used, a conventional ventilation tube is surgically placed in the eardrum. Patients then place an ear-cuff in the external ear canal and treat themselves for 3 minutes, 3 times daily. Treatment is continued for as long as patients find themselves in a period of attacks of vertigo.
The most recent literature review was updated through August 3, 2022.
Summary of Evidence:
For individuals who have Meniere disease who receive transtympanic micropressure therapy (Meniett), the evidence includes randomized controlled trials (RCTs) and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, and treatment-related morbidity. Six RCTs of positive pressure therapy have been reported, with 5 trials specifically investigating the Meniett device. A systematic reviews of 5 of these trials found that micropressure therapy does not result in a greater reduction in vertigo than placebo. The sixth trial also found no significant benefit of the transtympanic micropressure therapy for Meniere disease. The evidence is sufficient to determine that the technology is unlikely to improve the net health outcome.
Practice Guidelines and Position Statements
American Academy of Otolaryngology-Head and Neck surgery
In 2016, the American Academy of Otolaryngology-Head and Neck Surgery updated their position statement on the use of transtympanic micropressure: “We find that there is some medical evidence to support the use of micropressure therapy (such as the Meniett device) in certain cases of Meniere’s disease. Micropressure therapy is best used as a second level therapy when medical treatment has failed. The device represents a largely non-surgical therapy that should be available as one of the many treatments for Meniere’s disease.” No supporting evidence was provided.
National Institute for Clinical Excellence (NICE)
In 2012, guidance from the United Kingdom’s National Institute for Clinical Excellence (NICE) concluded that current evidence on the safety of micropressure therapy for refractory Meniere's disease is inadequate in quantity. Although there is some evidence of efficacy, it is based on limited numbers of patients. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit, or research.
U.S. Preventive Services Task Force Recommendations:
Meniere’s disease, Meniett, low-pressure pulse generator, transtympanic micropressure
APPROVED BY GOVERNING BODIES:
In 1999, the Meniett® device (Medtronic Xomed, Inc., Jacksonville, Florida) was cleared for marketing by the U.S. Food and Drug Administration (FDA) through the 510 (k) process as a symptomatic treatment of Meniere’s disease.
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.
Replacement battery for patient owned ear pulse generator, each
Pulse generator system for tympanic treatment of inner endolymphatic fluid
- American Academy of Otolaryngology – Head and Neck Surgery. AAO-HNS position on micropressure therapy. Available at www.entnet.org/Practice/micropressure.cfm.
- American Academy of Otolaryngology-Head and Neck Surgery. Meniere’s disease. www.entnet.org/healthinfo/balance/meniere.cfm.
- Gurkov R, Filipe Mingas LB, Rader T et al. Effect of transtympanic low-pressure therapy in patients with unilateral Meniere's disease unresponsive to betahistine: a randomised, placebo-controlled, double-blinded, clinical trial. J Laryngol Otol 2012; 126(4):356-62.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- National Institute for Clinical Excellence (NICE). Micropressure therapy for refractory Ménière's disease. NICE interventional procedure guidance 426. 2012. Available online at: //guidance.nice.org.uk/IPG426/Guidance/pdf/English. Last accessed August, 2013.
- National Institute on Deafness and Other Communication disorders. Health information: Ménière’s disease. www.nidcd.nih.gov/health/balance/meniere.asp.
- Russo FY, Nguyen Y, De Seta D, et al. Meniett device in Meniere disease: Randomized, double-blind, placebo-controlled multicenter trial. Laryngoscope. Feb 2017; 127(2):470-475.
- Shojaku H, Aoki M, Takakura H, Fujisaka M, Asai M, Tsubota M, Ito Y, Watanabe Y. Effects of transtympanic intermittent pressure therapy using a new tympanic membrane massage device for intractable Meniere's disease and delayed endolymphatic hydrops: a prospective study. Acta Otolaryngol. 2021 Oct;141(10):907-914. doi: 10.1080/00016489.2021.1942979. Epub 2021 Sep 14.
- Shojaku H, Takakura H, Asai M, Fujisaka M, Ueda N, Do TA, Tsubota M, Watanabe Y. Long-term effect of transtympanic intermittent pressure therapy using a tympanic membrane massage device for intractable meniere's disease and delayed endolymphatic hydrops. Acta Otolaryngol. 2021 Nov;141(11):977-983. doi: 10.1080/00016489.2021.1989485. Epub 2021 Oct 24.
- Syed MI, Rutka JA, Hendry J, et al. Positive pressure therapy for Meniere's syndrome/disease with a Meniett device: a systematic review of randomized controlled trials. Clin Otolaryngol. Jun 2015; 40(3):197-207.
- U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) 510(k) approvals. www.fda.gov/cdrh/pdf/k991562.pdf.
- U.S. Food and Drug Administration. FDA 510(k) marketing clearance information for the Meniett device. Available online at www.accessdata.fda.gov/cdrhdocs /pdf/K991562.pdf.
- van Sonsbeek S, Pullens B, van Benthem PP. Positive pressure therapy for Meniere's disease or syndrome. Cochrane Database Syst Rev. 2015; 3:CD008419.
Medical Policy Group, January 2003 (1)
Medical Policy Administration Committee, February 2003
Available for comment February 6-March 24, 2003
Medical Policy Group, September 2006 (1)
Medical Policy Group, September 2008 (1)
Medical Policy Group, September 2010 (1)
Medical Policy Administration Committee, September 2010
Medical Policy Group, October 2011 (1): Update to Key Points; no change to policy statement
Medical Policy Group, October 2012 (1): 2012 Update to Key Points and References
Medical Policy Panel, October 2013
Medical Policy Group, October 2013 (3): 2013 Updates to Description, Key Points and References; no change in policy statement
Medical Policy Panel, October 2014
Medical Policy Group, October 2014 (5): Literature search from August 2014 did not yield any updates to policy.
Medical Policy Panel, February 2016
Medical Policy Group, February 2016 (6): Updates to Key Points and References; no change to policy statement.
Medical Policy Panel, February 2017
Medical Policy Group, February 2017 (6): Updates to Key Points, Summary and References. No change to policy intent.
Medical Policy Panel, February 2018
Medical Policy Group, February 2018 (6): Updates to Description, Key Points and Practice Guidelines.
Medical Policy Panel, February 2019
Medical Policy Group, February 2019 (6): Updates to Key Points.
Medical Policy Panel, February 2020
Medical Policy Group, February 2020 (6): Updates to Key Points and Governing Bodies.
Medical Policy Group, March 2020 (6): Effective March 17, 2020 : Active Policy but no longer scheduled for regular literature reviews and updates.
Medical Policy Group, August 2021 (6): Reviewed by consensus. Updates to Key Points and References added. No new published peer-reviewed literature available that would alter the coverage statement in this policy.
Medical Policy Group, August 2022 (6): Reviewed by consensus. Updates to Key Points and References. No new published peer-reviewed literature available that would alter the coverage statement in this policy.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
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As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.